Zoely Tablets

How do I take Zoely?

• Zoely is an everyday pill, meaning quite simply, that you take one tablet every day. The tablets come in strips of 28 tablets, with 24 small white active tablets and 4 small yellow inactive tablets.
• Zoely tablets must be taken in the order specified on the pack, starting with the tablet marked one. The tablets also come with self-adhesive strips, each starting with a different day of the week. These are to show you on which day to take each tablet. Peel off a strip that starts with your starting day, eg, if you start the tablets on a Wednesday, use a strip that starts with 'Wed'. Stick the strip along the top of the strip of tablets, so that the first day is above the pill marked 'start'. You can now see on which day you have to take each tablet.
• The purpose of the last four inactive tablets is that you get used to taking a pill at the same time every day and just take each packet back to back. This is unlike many other pills, where you have three weeks of taking pills, followed by a week off from pill taking.
• You will still be protected against pregnancy while you are taking the inactive tablets, provided you took all the pills correctly, you start the next packet on time and nothing else happened that could make the pill less effective (eg sickness, diarrhoea, or taking certain other medicines - see below).
• You should try and take your pill at the same time every day to help you remember to take it. The tablets can be taken either with or without food.

When can I start taking it?

• If you have not previously been using a hormonal contraceptive you should take the first tablet on day one of your menstrual cycle (the first day of your period). This will protect you from pregnancy straight away and you don't need to use any additional contraception.
• If you are changing from any other combined oral contraceptive pill to Zoely, then you should take the first tablet of your Zoely packet the day after you take your last active pill from your old pill packet. This will protect you from pregnancy straight away.
• If you have previously been using the contraceptive vaginal ring (NuvaRing) or contraceptive skin patches (Evra) you need to start taking the Zoely tablets on the day you remove the ring or patch. This will protect you from pregnancy straight away.
• If you have previously been using a progestogen-only contraceptive pill, known as the mini pill, you can change over to Zoely on any day of the cycle, but you must use extra contraception such as condoms (or not have sex) for the first seven days of taking the Zoely tablets.
• If you are changing from other progestogen-only contraceptives, such as an implant (eg Nexoplanon), a hormone releasing coil (Mirena IUS) or an injection (eg Depo-Provera or Noristerat), Zoely tablets should be started on the day the implant or IUS is removed, or on the day your next injection is due. You will need to use extra contraception such as condoms for the first seven days of taking the Zoely tablets.
• You can start taking this pill immediately after a miscarriage or abortion in the first trimester; you will be protected against pregnancy immediately.
• If you have given birth and are not breastfeeding, or have had an abortion in the second trimester, you can start taking this pill at day 21 to 28 after the birth or second trimester abortion. You will be protected against pregnancy immediately and do not need to use extra contraception. If you start taking Zoely later than 28 days after the birth or abortion, you will need to use extra contraception eg condoms for the first seven days of taking the Zoely tablets. However, if you had unprotected sex after the birth or abortion and before starting Zoely tablets, you should do a pregnancy test or wait until your first menstrual period before you start taking Zoely, to make sure you are not already pregnant.

What do I do if I miss a pill?

• The Zoely packet contains 24 white active tablets and 4 yellow inactive tablets. These must be taken in the order specified on the pack.
• If you forget to take one of the yellow inactive pills this doesn't matter. You will still be protected, just discard the missed inactive pill and continue to take your pills, one every day, as normal.
• If you forget to take an active pill, you should take it as soon as you remember (even if that means taking two pills in one day) and then continue to take your pills, one every day, as normal. Don't take more than two active pills in one day. If you miss more than one pill you should ask your doctor for advice.
• If you are less than 12 hours late taking an active pill you will still be protected against pregnancy and don't need to use any extra precautions.
• If you are more than 12 hours late taking an active pill, you may not be protected against pregnancy. What to do next depends on where in the packet you missed the pill.
• If you have forgotten to start a new packet of pills, or have forgotten to take a pill on day 1 to 7 of the packet, you should take the missed tablet as soon as you remember and take the next tablet at the usual time. You should use extra contraception such as condoms for the next seven days, while continuing with normal pill taking. If you had unprotected sex within the previous seven days there is a possibility you could be pregnant and you should seek medical advice. You may need to take emergency contraception (the morning after pill).
• If you miss one pill on days 8 to17 of the packet, you should take the missed tablet as soon as you remember and take the next tablet at your usual time. You will not need to take extra precautions as the protection against pregnancy is not reduced. If you miss more than one pill in days 8 to 17 of the packet you should take one tablet as soon as you remember and then the next tablet at your usual time. In this case you will need to use a condom or not have sex for the next seven days, while continuing to take your pills as usual.

If you miss a pill from days 18 to 24 of the packet, there is a particularly high risk of becoming pregnant. This can be prevented without needing to use extra contraception by adjusting your schedule for the pill. This can be done in one of two ways:

Option one

• Take the missed pill as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the remaining active pills, one every day at your usual time, until all the active white tablets are used up. You should then skip the last four yellow tablets and start a new strip of tablets straight away.

Option two

• Stop taking the white active pills immediately and start taking the yellow inactive pills. After finishing the yellow inactive tablets a new strip of tablets should be started without a break.

If you are confused about any of this, you can get individual advice for your circumstances from your doctor, pharmacist or local family planning clinic.

What if I have vomiting or diarrhoea?

• If you vomit within three or four hours of taking a pill, it may not have been fully absorbed into your bloodstream. You should take another pill as soon as you feel well enough, within 12 hours of the usual time you take the pill. Take your next pill at your usual time. You should still be protected from pregnancy. However, if you continue to be you sick, or you took the other pill more than 12 hours after the usual time you take your pill, this may make your pill less effective. You should keep taking your pill at your normal time, but treat each day that you have vomiting as if you had forgotten to take a pill and follow the instructions under "what do I do if I miss a pill" above.
• If you have very severe diarrhoea for more than 24 hours, this may make your pill less effective. You should keep taking your pill at your normal time, but treat each day that you have severe diarrhoea as if you had forgotten to take a pill and follow the instructions under "what do I do if I miss a pill" above.

Zoely should not be used by

• Women who are breastfeeding (the combined pill shouldn't be taken until weaning or for six months after birth - see below for more information).
• Women who have ever had a blood clot in a vein (venous thromboembolism), eg in the leg (deep vein thrombosis) or in the lungs (pulmonary embolism).
• Women with blood disorders that increase the risk of blood clots in the veins, eg antiphospholipid syndrome or factor V Leiden.
• Women having sclerosing treatment for varicose veins.
• Women with two or more other risk factors for getting a blood clot in a vein, eg family history of deep vein thrombosis or pulmonary embolism before the age of 45 (parent, brother or sister), obesity, smoking, long-term immobility.
• Women who have ever had a heart attack, stroke or mini-stroke caused by a blood clot in an artery.
• Women with angina, heart valve disease or an irregular heartbeat called atrial fibrillation.
• Women with moderate to severe high blood pressure (hypertension).
• Women who smoke more than 40 cigarettes per day.
• Women over 50 years of age.
• Women over 35 years of age who smoke more than 15 cigarettes per day.
• Women with severe diabetes, eg with complications affecting the eyes, kidneys or nerves.
• Women with two or more other risk factors for getting a blood clot in an artery, eg family history of heart attack or stroke before the age of 45 (parent, brother or sister), diabetes, high blood pressure, smoking, high cholesterol levels, obesity, migraines.
• Women who get migraines with aura, severe migraines regularly lasting over 72 hours despite treatment, or migraines that are treated with ergot derivatives.
• Women with breast cancer or a history of breast cancer (although the pill can be used if you have been free of cancer for five years and you don't want to use non-hormonal methods of contraception).
• Women with abnormal vaginal bleeding where the cause is not known.
• Women with a long-term condition called systemic lupus erythematosus (SLE).
• Women with a history of excess of urea in the blood, causing damaged red blood cells (haemolytic uraemic syndrome).
• Women with active liver disease, eg liver cancer, hepatitis.
• Women with a history of liver disease when liver function has not returned to normal.
• Women with disorders of bile excretion that cause jaundice (eg Dubin-Johnson or Rotor syndrome).
• Women with gallstones.
• Women with a history of jaundice, severe itching, hearing disorder called otosclerosis, or rash called pemphigoid gestationis during a previous pregnancy, or previous use of sex hormones.
• Hereditary blood disorders known as porphyrias.
• Zoely tablets contain lactose and may not be suitable for women with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Zoely should be used with caution by

• Women aged over 35 years.
• Women whose parent, brother or sister had a heart attack or stroke caused by a blood clot before the age of 45.
• Women with a parent, brother or sister who has had a blood clot in a vein (venous thromboembolism), eg in the leg (deep vein thrombosis) or in the lungs (pulmonary embolism) before the age of 45.
• Smokers.
• Women who are obese.
• Women with diabetes mellitus.
• Women with high blood pressure (hypertension).
• Women with heart failure.
• Women who use a wheelchair.
• Women with a history of inflammation of a vein caused by a superficial blood clot (thrombophlebitis).
• Women with anaemia caused by a hereditary blood disorder where abnormal haemoglobin is produced (sickle cell anaemia).
• Women with a history of severe depression, especially if this was caused by taking the pill in the past.
• Women with a history of migraines (see above).
• Women with inflammatory bowel disease, eg Crohn's disease or ulcerative colitis.
• Women with a personal or family history of raised levels of fats called triglycerides in the blood (hypertriglyceridaemia).
• Women with raised levels of the hormone prolactin in their blood (hyperprolactinaemia).
• Women with an undiagnosed breast lump or gene mutations that are associated with breast cancer, eg BRCA1.
• Women with a history of irregular brown patches appearing on the skin, usually of the face, during pregnancy or previous use of a contraceptive pill (chloasma). Women with a tendency to this condition should minimise their exposure to the sun or UV light while taking this contraceptive.

Pregnancy and breastfeeding

• Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
• This medicine is used to prevent pregnancy and should not be taken during pregnancy. However, if the pill fails or you miss pills and you do get pregnant while taking it, there is no evidence to suggest that the pills you have already taken will harm the baby. If you think you could be pregnant while taking this pill you should stop taking it and consult your doctor immediately.
• The hormones in this pill can reduce the production of breast milk. For this reason, it is not recommended for women who are breastfeeding. It should not be used until weaning, or at least six months after the birth. Other methods of contraception are more suitable for women who are breastfeeding. Ask your doctor for advice.

Possible side effects of Zoely

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. See also the warnings above. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

• Nausea and vomiting.
• Abdominal pain.
• Headache/migraine.
• Breast tenderness and enlargement.
• Weight changes.
• Retention of water in the body tissues (fluid retention).
• Vaginal thrush (candidiasis).
• Change in menstrual bleeding, usually lighter periods or sometimes stopping of periods.
• Menstrual spotting or breakthrough bleeding.
• Depression.
• Decreased sex drive.
• Rise in blood pressure.
• Skin reactions.
• Irregular brown patches on the skin, usually of the face (chloasma).
• Steepening of corneal curvature, which may make contact lenses uncomfortable.
• Disturbance in liver function.
• Gallstones.
• Blood clots in the blood vessels (eg, DVT, pulmonary embolism, heart attack, stroke).

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

If you think you have experienced a side effect from a medicine or vaccine you should check the patient information leaflet. This lists the known side effects and what to do if you get them. You can also get advice from your doctor, nurse or pharmacist. If they think it''s necessary they'll report it for you.

How can Zoely affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start taking this contraceptive. Similarly, check with your doctor or pharmacist before taking any new medicines while using this one, to make sure that the combination is safe.

The following medicines speed up the breakdown of the hormones in this contraceptive by the liver, which makes it less effective at preventing pregnancy:

• aprepitant
• bosentan
• barbiturates
• carbamazepine
• cobicistat
• crizotinib
• dabrafenib
• eslicarbazepine
• modafinil
• nevirapine
• oxcarbazepine
• perampanel (12mg)
• phenobarbital
• phenytoin
• primidone
• rifampicin
• rifabutin
• ritonavir
• rufinamide
• telaprevir
• the herbal remedy St John's wort (Hypericum perforatum)
• topiramate
• vemurafenib.

If you regularly take any of these medicines, this contraceptive is not recommended for you, because these medicines are likely to make this contraceptive ineffective at preventing pregnancy. You should talk to your doctor about other contraceptive options.

If you are prescribed a short course (up to two months) of any of these medicines, your doctor will probably recommend that you temporarily use a different form of contraception to prevent pregnancy. It is important to discuss your options with your doctor.

If you are prescribed rifampicin or rifabutin, an alternative method of contraception will always be recommended, because these two antibiotics make the pill so ineffective.

In the past, if you were prescribed an antibiotic other than rifampicin or rifabutin (eg amoxicillin, erythromycin, doxycycline) while taking the pill, the advice used to be that you use an extra method of contraception (eg condoms) while you were taking the antibiotic and for seven days after finishing the course. However, this advice has now changed. You no longer need to use an extra method of contraception with the pill while you take a course of antibiotic. This change in advice comes because to date there is no evidence to prove that antibiotics (other than rifampicin or rifabutin) affect the pill. This is the latest guidance from the Faculty of Sexual & Reproductive Healthcare. However, if you experience vomiting or diarrhoea as a result of taking an antibiotic you should follow the instructions for vomiting and diarrhoea described in the warning section above.

The emergency contraceptive ulipristal (Ellaone) has the potential to make the pill less effective. If you take Ellaone as an emergency contraceptive while you are taking Zoely, you should use an additional method of contraception such as condoms for 14 days after you take it.

The antifungal medicine griseofulvin may make the pill less effective. You should use an extra method of contraception both during treatment with griseofulvin and for one month after stopping treatment.

The weight loss medicine orlistat (bought without a prescription as Alli and prescribed as Xenical) can cause severe diarrhoea. If you take either of these medicines while taking Zoely and get diarrhoea that lasts for more than 24 hours, you should follow the instructions for missed pills described above.

The pill may oppose the blood sugar lowering effect of medicines for diabetes. If you have diabetes you should monitor your blood sugar and seek advice from your doctor or pharmacist if your blood sugar control seems to be altered after starting this contraceptive.

The pill may oppose the effect of medicines used to lower high blood pressure. Your blood pressure will usually be checked periodically while you are taking the pill, but this is particularly important if you are also taking medicines for high blood pressure.

The pill may also oppose the fluid-losing effect of diuretic medicines.

If you have an underactive thyroid gland (hypothyroidism) you may need an increased dose of your thyroid hormones while taking the pill. Your thyroid hormone levels should be regularly checked.

The pill may decrease the amount of the antiepileptic medicine lamotrigine in the blood. As this could increase the risk of seizures coming back or getting worse, the pill may not be recommended for women who take lamotrigine on its own for epilepsy.

The pill may increase the blood levels of the following medicines and this could possibly increase the risk of their side effects:

• ciclosporin
• melatonin
• ropinirole
• selegiline (should be avoided in combination with the pill)
• tacrolimus
• theophylline (reduced dose of theophylline may be needed)
• tizanidine
• voriconazole.

References:

http://www.medicines.ie/medicine/15260/SPC

http://www.netdoctor.co.uk/medicines/sexual-health/a8895/zoely-estradiol-nomegestrol/

http://www.drugs.com/uk/zoely.html

https://www.medicines.org.uk/emc/PIL.27582.latest.pdf

http://www.pharmaceutical-journal.com/news-and-analysis/news/zoely-not-recommended-over-established-combined-oral-contraceptives/20066162.article